MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NEPHROMAX KIT; CATHETER, NEPHROSTOMY

Model Number	M0062101180
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a nephromax nephrostomy balloon catheter kit was used in the kidney during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2022.During the procedure, the balloon burst when inflated to 1 atm.The procedure was completed with another nephromax nephrostomy balloon catheter kit.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device problem code a0402 captures the reportable event of balloon burst.Block h10: investigation result the returned nephromax balloon device was analyzed, and a visual evaluation noted that the balloon was torn longitudinally from the proximal of the distal markerband extending proximal of the distal markerband.No problem was identified to the markerbands.A visual and tactile examinations revealed that there were no problems found to the tip and the shaft of the device.With all the available information, boston scientific concludes the reported event of balloon burst was confirmed.It is possible that the device had interaction with a stone, leading to the found problem of balloon torn longitudinally.Therefore, the most probable root cause is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax nephrostomy balloon catheter kit was used in the kidney during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2022.During the procedure, the balloon burst when inflated to 1 atm.The procedure was completed with another nephromax nephrostomy balloon catheter kit.There were no patient complications reported as a result of this event.The device was not returned.

• Brand Name: NEPHROMAX KIT
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15406987
• Report Number: 3005099803-2022-05067
• Device Sequence Number: 14862895
• Product Code: LJE
• UDI-Device Identifier: 08714729077589
• UDI-Public: 08714729077589
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K121614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/05/2024
• Device Model Number: M0062101180
• Device Catalogue Number: 210-118
• Device Lot Number: 0029028565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/18/2022
• Supplement Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown